lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4427
Product ID 70518-4427_4041479b-b6e5-6ca7-e063-6294a90a371f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208031
Listing Expiration 2026-12-31
Marketing Start 2025-08-06

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184427
Hyphenated Format 70518-4427

Supplemental Identifiers

RxCUI
1040031
UNII
O0P4I5851I

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lurasidone hydrochloride (source: ndc)
Generic Name lurasidone hydrochloride (source: ndc)
Application Number ANDA208031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-4427-0)
source: ndc

Packages (1)

70518-4427-0 30 TABLET in 1 BLISTER PACK (70518-4427-0)

Ingredients (1)

lurasidone hydrochloride (40 mg/1)

Linked Drug Pages (1)

lurasidone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4041479b-b6e5-6ca7-e063-6294a90a371f", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031"], "spl_set_id": ["5dc04e98-e41c-40cb-9037-d29084c9bf6d"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4427-0)", "package_ndc": "70518-4427-0", "marketing_start_date": "20250806"}], "brand_name": "lurasidone hydrochloride", "product_id": "70518-4427_4041479b-b6e5-6ca7-e063-6294a90a371f", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-4427", "generic_name": "lurasidone hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA208031", "marketing_category": "ANDA", "marketing_start_date": "20250806", "listing_expiration_date": "20261231"}